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Phase I Study of E7050 in Patients with Advanced Solid Tumours

  • Research type

    Research Study

  • Full title

    A Phase I Dose-Finding Study of E7050 Administered Orally to Patients with Advanced Solid Tumours

  • IRAS ID

    6248

  • Contact name

    R Molife

  • Sponsor organisation

    Eisai Limited

  • Eudract number

    2008-002189-76

  • Clinicaltrials.gov Identifier

    NCT00869895

  • Research summary

    c-Met, is a protein that, when in excess amounts, can drive the growth of many cancers including those of the stomach, lung, breast, prostate and kidney. Another protein, vascular endothelial growth factor (VEGF) and its receptor VEGFR, are also implicated in the growth of cancers, by promoting the growth of blood vessels within cancers allowing nutrients to be transported to and waste transported from growing cancers. E7050 is a new compound that blocks the action of c-Met and VEGFR and may therefore slow the growth of several cancer types. The main purpose of this study is to identify the highest safest dose of E7050, which could then be further investigated in future clinical trials. Other aims are to define the safety, effectiveness and pharmacokinetics (how E7050 is absorbed, broken down and excreted by the human body) of E7050. Groups (cohorts) of 3 to 6 patients will be recruited to escalating dose levels of E7050, until this dose is defined. The increase in doses will depend on the side effects seen in the previous group of patients. The study will take place at 2 hospitals in the UK and is funded by the pharmaceutical company, Eisai Limited.While on treatment, patients will attend the hospital for 2 overnight stays at the beginning of the 1st 2 cycles. They will then attend for study assessments to evaluate PK and safety on a weekly basis. Computed tomography (CT) or magnetic resonant imaging (MRI) scans to determine the effect of E7050 on the growth of the patient's cancer will be performed every 8 weeks. Study treatment can continue until evidence of progressive disease, unacceptable side effects, or withdrawal of patient's consent. Within 30 days after the end of study treatment, the patient will be asked to return for a final study visit.

  • REC name

    London - City & East Research Ethics Committee

  • REC reference

    08/H0703/141

  • Date of REC Opinion

    4 Feb 2009

  • REC opinion

    Further Information Favourable Opinion